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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device gases used within eye to place pressure on detached retina
Regulation Description Intraocular gas.
Product CodeLPO
Regulation Number 886.4270
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 1 1 3 0 2 0 0 0 0

Device Problems
Device operates differently than expected 11
No code available 9
No Known Device Problem 8
Use of Device Issue 8
Mechanical jam 7
No Information 7
Other (for use when an appropriate device code cannot be identified) 5
Sticking 5
Failure to deliver 4
Difficult to open or close 3
Unknown (for use when the device problem is not known) 3
Defective component 3
Performance 3
Incorrect or inadequate result 2
Break 2
Filling problem 2
Defective item 2
Unexpected therapeutic results 2
Delivery system failure 2
No flow 1
Packaging issue 1
Pressure issue 1
Device inoperable 1
Device Issue 1
Device, removal of (non-implant) 1
Improper gas output 1
Short fill 1
Total Device Problems 96

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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